The Food and Drug Administration has given tentative approval to Dr. Reddy’s Laboratories to make a generic version of lenacapavir, the HIV prevention medicine given by injection once every six months, according to STAT. The company plans to start shipping the medicine next month, at an annual cost of 40 dollars per person, comparable to daily prevention tablets, as part of an effort backed by global health organisations to supply dozens of low and middle income countries. The brand name version, Yeztugo, is sold by Gilead Sciences and was approved by the FDA last year.
FDA gives tentative approval to generic HIV prevention shot
The FDA has given tentative approval to Dr. Reddy's Laboratories for a generic version of lenacapavir, the twice yearly HIV prevention injection sold by Gilead as Yeztugo, at a planned cost of 40 dollars per person per year.
Why it matters: A generic at that price puts the six monthly injection within reach of prevention programmes in the low and middle income countries where most new HIV infections occur.
Data as of STAT report of November 2, 2026, read in this run; the article is subscriber limited and the approval is single sourced to STAT in this run, so this item is grade C. Tentative approval is the status STAT reports; it is not a final US marketing approval. Developing item.
Sources
- FDA approves generic version of HIV prevention shot lenacapavir - STAT - 2026-11-02